Sterilization system and method with temperature-controlled condensing surface

ABSTRACT

A chemical vapor sterilization process is enhanced by concentrating a germicide via condensation and re-vaporization thereof, exploiting the difference between the vapor pressures of the germicide and its solvent to extract some of the solvent during the condensation process.

This application is a continuation-in-part of U.S. application Ser. No.10/186,109 filed Jun. 28, 2002.

FIELD OF THE INVENTION

The invention relates to sterilization of articles, and moreparticularly to sterilization of articles which involves the step ofvaporizing a liquid chemical sterilant solution.

BACKGROUND OF THE INVENTION

It is known to sterilize articles with a vaporized chemical sterilant,such as hydrogen peroxide, peracetic acid and glutaraldehyde. Wu et al.U.S. Pat. No. 6,365,102, incorporated herein by reference, describes ahydrogen peroxide/gas plasma sterilization system comprising a vacuumchamber, source of hydrogen peroxide vapor and a source of RF energy tocreate a plasma. Such systems marketed under the name STERRAD® areavailable from Advanced Sterilization Products division of Ethicon, Inc.in Irvine, Calif.

Jacobs et al., U.S. Pat. No. 6,325,972 found that when the water has ahigher vapor pressure than the sterilant component of the solution, sucha solution of hydrogen peroxide, that by controlling the temperature andpressure at which the solution is vaporized the water can bepreferentially drawn off from the solution to increase the concentrationof the sterilant in the solution. If the water is exhausted from thesystem during this process it leaves a higher concentration of thesterilant in the system. The higher concentration of sterilant duringthe phase in which the vapor phase sterilant contacts articles to besterilized leads to increased efficiency in the sterilization process.

SUMMARY OF THE INVENTION

A method, according to the present invention, of providing a sterilantvapor for sterilizing an article comprises the steps of: a) placing thearticle into a sterilization chamber; b) vaporizing a liquid sterilantsolution comprising a solvent and a sterilant to form a sterilant vapor;c) condensing at least a portion of the sterilant vapor onto atemperature controllable surface; d) evacuating an atmosphere adjacentthe surface, the atmosphere containing vaporized solvent, therebyleaving the condensed sterilant vapor with a higher concentration ofsterilant than in step b); e) revaporizing the sterilant vapor which wascondensed onto the surface; and f) contacting the article with thesterilant vapor which has been revaporized.

Preferably, the surface is cooled to enhance condensation during step c)and further is heated to enhance revaporization during step e).

In one aspect of the invention, the surface is located within thesterilization chamber. It can also be located in a condenser which is influid communication with the chamber. Preferably, sterilant vapor fromstep b) is flowed into the chamber, from the chamber into the condenser,and then step c) is performed. Preferably, the atmosphere which isevacuated passes out of the condenser without further passing throughthe chamber. It is preferred to isolate the condenser from thesterilization chamber during step d).

In one aspect of the invention, the surface is used to vaporize theliquid sterilant solution in step b).

Steps c), d) and e) can be repeated to further concentrate thesterilant.

An apparatus, according to the present invention, for delivering asterilant vapor to an article during a sterilization process comprises asterilization chamber for containing the article, a vaporizer in fluidcommunication with the sterilization chamber, a temperature controllablecondensing surface within or in fluid communication with thesterilization chamber, and a vacuum pump in fluid communication with thecondensing surface.

Preferably, a cooler is associated with the condensing surface wherebyto cool the condensing surface. Further, a heater can be associated withthe condensing surface whereby to heat the condensing surface.

In one aspect of the invention, the condenser is located between thevaporizer and the chamber. The condenser can also be located between thechamber and the pump. Condensers in both locations may be included.

Preferably, a valve is provided between the condenser and thesterilization chamber whereby to isolate the condenser from thesterilization chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a sterilization system according to thepresent invention;

FIG. 2 is a block diagram of a vaporizer and diffusion path of thesterilization system of FIG. 1;

FIG. 3 is a block diagram of an alternate embodiment of a sterilizationsystem according to the present invention;

FIG. 3A is a block diagram of an alternative embodiment of asterilization system according to the present invention.

FIG. 3B is a sectional view taken along lines 3B-3B of FIG. 3A;

FIG. 4 is a block diagram of an alternate embodiment of a sterilizationsystem according to the present invention;

FIG. 5 is a block diagram of an alternate embodiment of a sterilizationsystem according to the present invention;

FIG. 6 is a section view taken along lines 6-6 of FIG. 5;

FIG. 7 is a block diagram of an alternate embodiment of a sterilizationsystem according to the present invention;

FIG. 8 is a section view taken along lines 8-8 of FIG. 7;

FIG. 9 is a block diagram of a sterilization system according to thepresent invention;

FIG. 10 is a cut-away view of an outlet condenser/vaporizer for use inthe system of FIG. 9;

FIG. 11 is a cut-away view of an inlet condenser/vaporizer for use inthe system of FIG. 9;

FIG. 12 is a perspective view of an alternative inletcondenser/vaporizer for use in the system of FIG. 9;

FIG. 13 is an exploded perspective view of the condenser/vaporizer ofFIG. 12;

FIG. 14 is a section view taken along lines 14-14 of FIG. 12;

FIG. 14A is a close-up section view of the valve assembly shown in FIG.14;

FIG. 15 is an exploded perspective view of a thermoelectric heat pumpand rod assembly employed in the condenser/vaporizer of FIG. 12;

FIG. 16 is an alternative sterilization system according to the presentinvention;

FIG. 17 is an alternative sterilization system according to the presentinvention;

FIG. 18 is an alternative sterilization system according to the presentinvention; and

FIG. 19 is an alternative sterilization system according to the presentinvention.

DETAILED DESCRIPTION

FIG. 1 shows in block diagram form a sterilization system 10 comprisinga sterilization chamber 12, a vaporizer 14, and a vacuum pump 16. Thevacuum pump is capable of drawing a vacuum on the chamber, preferably aslow as 0.5 torr. Between the vacuum pump 16 and the chamber 12, ispreferably located at throttle valve 18 and optionally an orifice plate20. The throttle valve 18 preferably also has good shut-off capability.A pressure gauge 22, preferably located adjacent to the throttle valve18, shows the vacuum in the chamber 12. A vent valve 23 employing a HEPAantimicrobial filter allows clean sterile air to enter the chamber 12.The vaporizer 14 connects to the chamber 12 by means of an elongateddiffusion path 24. Turning also to FIG. 2, the diffusion path 24incorporates temperature control elements 26 to control the temperaturealong the diffusion path 24.

Vaporizers suitable for vaporizing a liquid sterilant such as hydrogenperoxide solution are known in the art. Kohler et al. U.S. Pat. No.6,106,772 and Nguyen et al. U.S. patent application Ser. No. 09/728,973filed Dec. 10, 2000, both incorporated herein by reference, illustratevaporizers suitable for the present application. In its simplest for thevaporizer can comprise a small chamber into which the liquid hydrogenperoxide solution is injected. The low pressure in the vaporizer causedby the vacuum in the chamber causes the hydrogen peroxide solution tovaporize.

Preferably, the vaporizer 14 itself incorporates heating elements 28which control the temperature in the vaporizer to optimize thevaporization process. Preferably, where the vaporizer 14 connects to thediffusion path 24 some form of thermal insulation 30 provided at theinterface so that the high temperatures of the vaporizer 14 will notunduly affect the temperature in the diffusion path 24. The vaporizer 14and diffusion path 24 are preferably formed of aluminum; the thermalinsulation 30 can take the form of a polyvinyl chloride (PVC) jointconnecting the two together.

Further, it is preferable to include a heater 32 inside the chamber 12,preferably near a lower portion of the chamber 12 for revaporizingcondensed hydrogen peroxide inside the chamber 12.

The chamber 12 preferably includes a mechanism (not shown) to create aplasma therein. Such mechanism can include a source of radio or lowfrequency energy as described by Jacobs et al. U.S. Pat. No. 4,643,867,or by Platt, Jr. et al. in published U.S. Application Document No.20020068012, both of which are incorporated herein by reference.

The present invention achieves its beneficial effect by allowing some ofthe hydrogen peroxide which is vaporized out of solution in thevaporizer 14 to condense onto the diffusion path 24. After most of thehydrogen peroxide solution has vaporized, the temperature controlelements 26 raise the temperature of the diffusion path to allow thecondensed hydrogen peroxide to re-vaporize. Water has a higher vaporpressure than hydrogen peroxide, thus hydrogen peroxide in the vaporcondenses more easily than water. Thus, the material which condenses inthe diffusion path will have a higher concentration of hydrogen peroxidethan the starting concentration of the hydrogen peroxide solution in thevaporizer 14.

The temperature control elements 26 in simple form can comprise mereelectric resistance heaters. In such case, the low ambient temperatureof the diffusion path 24 provides the low temperature for condensinghydrogen peroxide thereon, and the control elements 26 later heat thediffusion path 24 to re-vaporize the now more highly concentratedhydrogen peroxide from the diffusion path 24. Because the vapor pressureof hydrogen peroxide drops with lower temperatures, lower initialtemperatures in the diffusion path 24 allows a lower pressure in thechamber 24 without subsequently preventing the condensation of hydrogenperoxide in the diffusion path. Lower chamber pressures promote systemefficiency and thus, the temperature control elements 26 can furthercomprise a chilling component to lower the temperature of the diffusionpath below ambient. Suitable chilling components include thermoelectriccoolers or a typical mechanical refrigeration system. In such case, thediffusion path 24 would be first chilled, preferably to about 10° C.,and then some time after vaporization has begun or even after it hascompleted, the diffusion path 24 is then heated, preferably up to 50° C.or 110° C.

When vertically oriented as in FIG. 2, the diffusion path 24 canpotentially cause the vaporizing sterilant to condense in cooler regionsbetween the temperature control elements 26 and then re-vaporize as itpasses the temperature control element 26.

The following example illustrates the benefits of controlling the heatin the diffusion path.

EXAMPLE 1

The efficacy tests were conducted by placing a CSR-wrapped tray(3.5″×10″×20″) consisting of representative medical devices and testlumens in a 20-liter aluminum chamber (4.4″×12″×22″). A one-inchstainless steel wire inoculated with at least 1×10⁶ Bacillusstearothermophilus spores was placed in the center of each of the testlumens. The effects with and without temperature control of thediffusion path were investigated with both a TEFLON,poly(tetrafluoroethylene)lumen having an internal diameter of 1 mm and alength of 700 mm, and a stainless steel lumen having an internaldiameter of 1 mm, and a length of 500 mm. All lumens were open at bothends. Each of the samples were subjected to a sterilization cycle in a20 liter vacuum chamber, which was held at 40° C. and 3 torr for 5minutes. 1.44 ml of a 59% solution of hydrogen peroxide in water wasinjected at atmospheric pressure into the vaporizer which was held at60° C. The 5 minute clock then started and the chamber was pumped downto 3 torr, which took less than one minute. In one case the diffusionpath 24 had an initial temperature of 30° C. for the first minute whilethe chamber was evacuated to 3 torr and was then heated to 50° C. torelease the condensed peroxide from the diffusion path into the chamberfor the remainder of the cycle while pressure was maintained at 3 torr.In the other case, the diffusion path was held at 50° C. throughout thecycle. By maintaining the diffusion path at 50° C., no or littleperoxide was retained in the diffusion path. Sterilization effectivenesswas measured by incubating the test samples in growth media at 55° C.and checking for growth of the test organism. Table 1 shows the resultsof these tests. TABLE 1 30° C. 50° C. Diffusion Diffusion Path For OnePath Minute Then Throughout increased to Lumen Type ID & Length Process50° C. Teflon 1 × 700 2/2 0/3 Stainless 1 × 500 1/2 0/3 Steel

When the diffusion path temperature was maintained at high temperaturethroughout the process, all of the samples in the TEFLON lumen testedpositive for bacteria growth, indicating failure of sterilization, andone of two samples in the stainless steel lumen tested positive. Underthe same conditions, but with an initially lower temperature diffusionpath which was heated starting one minute after the diffusion began,none of the samples tested positive. Condensing the peroxide in thediffusion path during the initial vaporization stage and thenre-vaporizing the condensed peroxide from the diffusion path into thechamber greatly enhance the efficacy.

Additional efficiencies can be achieved by alternating cool and warmregions in the diffusion path 24 as primarily illustrated in FIG. 2. Thetemperature control elements 26, in simple form heating elements, arespaced apart from one another. Also, preferably, the diffusion path 24is vertical in this respect. As the hydrogen peroxide solution vaporizesand passes through the diffusion path 24, it is thought that it mayalternately condense and re-vaporize as it passes over the heated andunheated sections of the diffusion path 24. The diffusion path couldalternatively comprise alternating heating and cooling elements.

The heater 32 within the chamber 12 acts similarly to the heating of thediffusion path 24. By controlling the heater 32 temperature, theperoxide can be first condensed on the heater 32 and then re-vaporizedinto the chamber 12 to concentrate the peroxide.

A preferred cycle would be a modification of a cycle described in the Wuet al. U.S. Pat. No. 6,365,102, incorporated herein by reference. Aseries of pre-plasma energy additions with venting in-between driesmoisture from the chamber 12. A vacuum is then drawn upon the chamber 12and the hydrogen peroxide solution injected into the vaporizer 14.Alternatively, the peroxide solution can also be injected at atmosphericpressure. Some of the vaporizing solution condenses upon the cooldiffusion path 24. After a time sufficient for most or all of thehydrogen peroxide solution to vaporize from the vaporizer 14, thediffusion path 24 is warmed by the temperature control elements 26 andthe condensed hydrogen peroxide solution re-vaporizes. At about thistime, the throttle valve 18 is closed and the pump 16 turned off to sealthe chamber 12. Much of the water fraction of the hydrogen peroxidesolution has thus been drawn out of the chamber 12 by the vacuum pump 16and the remaining hydrogen peroxide solution which re-vaporizes from thediffusion path 24, or from the heater 32 in the chamber 12 if present,is of a higher hydrogen peroxide concentration than the startingsolution. Preferably, a computer based control system (not shown)controls the functions of the process for ease and repeatability.

The hydrogen peroxide vapor thus produced contacts an article 34 orarticles 34 in the chamber 12 and effects sterilization thereof. Ifthose articles 34 have diffusion restricted areas, such as long, narrowlumens, it may be preferable to then vent the chamber 12 and allow cleansterile air therein to drive the hydrogen peroxide vapor deeper into thediffusion restricted areas. Then the chamber 12 is again subjected tovacuum and an additional injection of hydrogen peroxide, preferably withthe heating sequence on the diffusion path, is repeated. After a timeperiod sufficient to effect sterilization of the article 34, preferablywith a six-log reduction in challenge organisms such as Bacillusstearothermophilus, a plasma is lit within the chamber 12, therebyenhancing the sterilization and breaking down the hydrogen peroxide intowater and oxygen.

The orifice plate 20 can enhance the effect of concentrating thehydrogen peroxide during its vaporization. As described in the Lin etal. U.S. Pat. No. 5,851,485, incorporated herein by reference, acontrolled or slow pump-down of the chamber 12 initially draws off morewater than hydrogen peroxide from solution as the water has a highervapor pressure, thereby leaving a higher concentration hydrogen peroxidebehind. Controlling the pump-down can be difficult as vacuum pumpsgenerally do not throttle back well and throttle valves in such serviceare difficult to control and expensive. By placing the orifice plate 20in the flow path to the pump 16, the amount of atmosphere from thechamber 12 exhausted by the pump 16 is limited, and by selecting aproper size orifice 36 in the plate 20 can be controlled to a rate whicheffectively concentrates hydrogen peroxide in the chamber 12.

Turning also to FIG. 3, a system 10 a, similar in most respects to thesystem 10 of FIGS. 1 and 2, with like part numbers denoted with an “a”appended thereto, also incorporates an orifice plate 20 a. However, toallow a quick pump-down of the chamber 12 a, yet retain the controlledpump-down benefits of the orifice plate 20 a, it incorporates two pathways from the pump 16 a to the chamber 12 a. A first pathway 40 containsa throttle valve 42 and a second pathway 44 contains a throttle valve 46and the orifice plate 20 a. Thus, during initial pump-down the firstthrottle valve 42 is open leaving the pump 16 a freely connected to thechamber 12 a. As the chamber 12 a approaches the vapor pressure ofwater, the first throttle valve 42 is closed thereby forcing the pump 16a to evacuate through the orifice plate 20 a and thus draw out of thechamber 12 a at a slower, controlled rate more conducive topreferentially drawing water out of the hydrogen peroxide solution andout of the chamber 12 a.

Turning also to FIGS. 3A and 3B, a system 110 similar to that of FIG. 1is shown. Here, rather than use two paths as in the system 10 a of FIG.3, a valve 112 comprises a valve body 114, a valve seat 116 and a valveelement 118, such as a butterfly disc, plug or the like. An orifice 120is provided through the valve element. Thus, when the valve 112 is openevacuation can occur quickly, and when the valve 112 is closed it canoccur more slowly. Such a valve could also be employed between thevaporizer 14 and the chamber 12 to further control the preferentialvaporization and removal of the water from the germicide solution.

Turning now to FIG. 4, while highly concentration of the sterilizingvapor is helpful in achieving sterilization efficiency and efficacy,getting the vapor into contact with the items to be sterilized is also aconcern. Typically, the low pressures (0.5 torr to 10.0 torr) inside ofa chamber 12 promotes quick diffusion of the sterilant vapor to allareas therein.

FIG. 4 illustrates a sterilization system 60 comprising a chamber 62having a vaporizer 64, vacuum pump 66 and vent 68 connected thereto.Preferably, an elongated, temperature controlled diffusion path 70 aspreviously described connects the vaporizer 64 to the chamber 62. Athrottle valve 72 and pressure gauge 74 are provided at the pump 66.

Articles 76 to be sterilized are placed into trays or containers 78. Twotypes of packaging are commonly used in preparing articles 76 forsterilization. In one, the articles 76 are placed into a tray having aplurality of openings therein, and the tray is then wrapped with amaterial such as CSR wrap which passes sterilizing gases and blockscontaminating microorganisms. Such a tray is described in the Wu, U.S.Pat. No. 6,379,631, incorporated herein by reference. An alternativepackage comprises a sealable container with several ports, preferably ontop and bottom surfaces thereof, with each of the ports covered by asemi-permeable membrane which passes sterilizing gases and blocksadmission of contaminating microorganisms. Such a container is describedin Nichols U.S. Pat. No. 4,704,254, incorporated herein by reference.The first type of packaging is typically called a “tray” and the seconda “container.” However, the term “container” as used herein is meant torefer to any container, packaging or enclosure suitable for containingarticles to be sterilized in a chemical vapor environment.

The pump 66 connects to the chamber 62 via an exhaust manifold 80. Themanifold 80 comprises one or more shelves 82 for supporting andreceiving one or more containers 78 and which connect fluidly throughthe throttle valve 72 to the pump 66. An opening, or preferably aplurality of openings 84 on the upper surfaces of the shelves 82 allowthe pump 66 to draw atmosphere within the chamber 62 through theopenings 84, through the manifold 80 and out through the pump 66.

The containers 78 preferably have openings 86 on a lower surface 88thereon and additional openings 90 on at least one other surface. Whenthe containers 78 are placed on the shelves 82 atmosphere beingexhausted by the pump 66 is drawn in part through the openings 90 intothe container 78, through the container into contact with the article orarticles 76 therein and then out through the openings 86 into themanifold 80 through the openings 84 therein. When the atmosphere beingso exhausted contains a sterilizing gas it enhances its penetration intothe containers 78 and into contact with the articles 76 therein.

Sterilizing gases are so exhausted during the previously described cycleas the sterilant solution is vaporizing and immediately before thesecond admission of hydrogen peroxide. Such a cycle can also furtherprovide a pump-down after some period of diffusion. After admitting thesterilant vapor the chamber 62 pressure rises slightly due to thepresence of additional gas therein, typically from about 0.5 torr toabout 10 torr. Higher pressures are as efficient with higher load andchamber temperatures.

Turning also to FIGS. 5 and 6, an alternative design (in which like partnumbers to those of the design of FIG. 4 are designated with a “b”appended thereto) replaces the manifold 80 of the design of FIG. 4 witha simple port 92. The port 92 is covered by a support 94 for thecontainer 78, the support 94 having a plurality of openings 96therethrough so that the chamber 62 b is in fluid communication with thepump 66 b through the container 78, the support 94 and the port 92. Thesupport 94 can be removable.

Turning also to FIGS. 7 and 8 (in which like part numbers to those ofthe designs of FIGS. 4 to 6 are designated with a “c” appended thereto)shows a support 100 resting on a surface 102 in the chamber 62 c throughwhich penetrates the port 92 c. The support 100 surrounds the port 92 c.Thus, most or all of the atmosphere being exhausted by the pump 66 cpasses through the container 78 into a space 104 formed between thecontainer 78, the support 100 and the surface 102 and then onto the pump66 c through the port 92 c.

FIG. 9 discloses an alternative system in which, similar to the systemof FIG. 1, a portion of the vaporized germicide solution can becondensed and the solvent, typically water, which has not condensed asquickly is removed from the atmosphere to further concentrate thegermicide. The germicide is then revaporized to produce a moreconcentrated germicidal vapor for more efficient sterilization. Thesystem comprises a sterilization chamber 200 containing a load 202 ofitems to be sterilized. A source 204 of liquid germicide solutionprovides the solution through a valve 206 to a first vaporizer/condenser208 where it is vaporized and then supplied to the chamber 200. A valve210 can be provided to isolate the vaporizer/condenser 208 from thechamber 200. The chamber 200 is also provided with a valved vent 212.

A vacuum pump 214 provides for lowering the chamber pressure asdescribed in reference to the previous embodiments. Between the pump 214and the chamber 200 a second vaporizer/condenser 216 is provided forcondensing the vaporized solution. Preferably valves 218 and 220 isolatethe second vaporizer/condenser 216 from the pump 214 and chamber 200respectively.

Turning also to FIG. 10 a simple version of the secondvaporizer/condenser 216 preferably comprises walls 222 defining anenclosure 224 having an inlet 226 connected to the chamber 200 and anoutlet 228 connected to the pump 214. A plurality of baffles 230provides a torturous flow path 232 through the vaporizer/condenser 216.The walls 222, and potentially the baffles 230, are temperaturecontrollable to enhance condensation of and re-vaporazation of thesolution.

A similar structure with an inlet can be employed on the firstvaporizer/condenser 208 as well. Turning also to FIG. 11, a simpleversion of the first condenser/vaporizer 208 is illustrated. Itcomprises an enclosure 240 having an inlet 242 connected to the sourceof solution 204 (not shown in FIG. 11) and an outlet 244 connected tothe chamber 200 (not shown in FIG. 11). A plurality of baffles 246provides a tortuous flow path through the first vaporizer/condenser 208.The enclosure 240 and potentially the baffles 246 are temperaturecontrollable to enhance condensation and revaporization of the solution.

In a simple cycle, a liquid germicide solution, such as hydrogenperoxide and water is admitted into the first vaporizer/condenser 208where it is vaporized and then flows into the chamber 200 which is at alow pressure, all as described in reference to previous embodimentsherein. During vaporization and for sometime thereafter pump 214continues to exhaust atmosphere from the chamber 200. By controllingtemperature and pressure this preferentially vaporizes water from thesolution over the hydrogen peroxide and the water vapor is extractedfrom the system via the pump 214 to concentrate the hydrogen peroxidesolution during the vaporization phase. Additionally, hydrogen peroxide,having the lower vapor pressure, will tend to condense more quickly thanthe water vapor in the first vaporizer/condenser 208. As the pump 214continues to exhaust atmosphere from the chamber 200 the vaporizedhydrogen peroxide solution flows out of the chamber and into the secondvaporizer/condenser 216 where a portion thereof will condense. Due tothe preferential condensation of hydrogen peroxide over the water moreof the water vapor will pass through the condenser 216 uncondensed andbe exhausted via the pump 214 thus allowing further concentration of thehydrogen peroxide solution. At some point, the pump is turned off andthe valve 218 closed. The condensed hydrogen peroxide within thevaporizer/condenser 216 is then re-vaporized preferably by heating thecondenser 216. This hydrogen peroxide will have a higher concentrationfor more efficient sterilization of the load 202.

Turning also to FIGS. 12 through 15, a more elaboratecondenser/vaporizer 250 is illustrated. In gross, it comprises an inletmanifold 252 which connects to the source of sterliant solution 204 andwhich provides initial vaporization, a condensing/revaporization section254, an outlet manifold 256 and a control valve 258 via which thevaporizer/condenser 250 connects to the chamber 200. A resistance heater260 affixes to the inlet manifold 252 and to the outlet manifold 256 toprovide heat to assist in the initial vaporization within the inletmanifold 252 and to prevent condensation in the outlet manifold 256.Preferably, the inlet manifold 252 and outlet manifold 256 are formed ofaluminum. Further, an insulator 262 is provided between the inletmanifold 252 and the vaporizer/revaporizer section 254.

The vaporizer/revaporizer section 254 comprises a housing 264,preferably formed of aluminum, open on a first side 266 and second side268. A first thermo-electric device 270 and second thermo-electricdevice 272 affix to the first side 266 and second side 268,respectively. The thermoelectric devices 270 and 272 preferably operateunder the Peltier effect, although other classes of thermoelectricdevices could be substituted therefor. More conventional heat pumps,such as freon or ammonia based systems can also be employed withsomewhat greater complexity.

A first rod assembly 274, comprising a plate 276 and a plurality of rods278 extending normally therefrom affixes to the first thermo-electricdevice 270 with the rods 278 extending laterally into the housing 264. Asecond rod assembly 280 similarly attaches to the second thermo-electricdevice 272 with its rods 278 extending laterally into the housing 264 infacing relationship to the first rod assembly 274. The rod assemblies274 and 280 are preferably formed of aluminum.

Preferably, the rods 278 extend almost to, without touching, theopposing plate 276. Also, the rods 278 from the two rod assemblies 274and 280 lie in a generally parallel relationship with each other with aspacing therebetween designed to, along with the volume within thevaporizer/revaporizer section 254, provide a preferred flow rate of thevaporized sterliant therethrough to provide efficient condensation on tothe rods 278. Preferably, a flow rate is in the range of 0.1 ft/sec to 5ft/sec, and more preferably a flow rate of 0.24 ft/sec is provided.

In a small condenser with a vapor path length of 3 inches, the residencetime would be 1 second at a preferred velocity of 0.24 ft/sec. Thisresidence time would be sufficient for the vaporized sterilant tointeract with the cooler condenser surfaces and to condense. For atypical injection volume of 2 ml of sterilant solution, the surface areaof the condensing/revaporization section 254 would be about 90 squareinches to permit mass transfer for condensation. High temperature at lowpressure in the initial vaporizer (inlet manifold 252) maintains thewater and hydrogen peroxide in the vapor phase for delivery to thecondensing/revaporization section 254. For example, a vaporizertemperature of 70 degrees C. or greater at a pressure of 125 torr orlower ensures that a 59 wt % solution of hydrogen peroxide and waterwill be in the vapor phase.

As vapor enters the condensing/revaporization section 254, which has alower temperature, the hydrogen peroxide condenses on the cooler surfaceforming a concentrated solution. The temperature and pressure thereindetermine the concentration of the condensed solution. For example, at50 degrees C. and 13 torr in the condensing/revaporization section 254,the condensed hydrogen peroxide concentration would be 94 wt %. At 30degrees C. and 3.8 torr, the condensed hydrogen peroxide concentrationalso would be 94 wt %. As the pressure in the condensing/revaporizationsection 254 is lowered, the temperature must also be lowered to maintainthe same concentration of solution.

The orifice 308 offers the advantage of a more concentrated solution byrestricting the flow from the condensing/revaporization section 254 toprovide a more controlled vaporization. Variations in pressure in thecondensing/revaporization section 254 and in the vaporizer due to vacuumpump pressure fluctuations are dampened out by the orifice 308 toprevent surges of water vapor from carrying hydrogen peroxide dropletsfrom the condensing/revaporization section 254. Another advantage offlow restriction by the orifice 308 is achieving a low pressure (lessthan 1 torr) in the sterilization chamber 200 to improve the diffusioncoefficient in lumens while maintaining a greater pressure in thevaporizer/condenser 250 to operate at a greater temperature in thecondensing/revaporization section 254. Without an orifice 308,sterilization chamber 200 and vaporizer/condenser 250 pressures mustboth be reduced to the same low pressure together, and the condensermust be operated at a very low temperature to maintain equilibrium ofthe solution. A lower condenser temperature is more difficult to controland may produce ice or condensate, which requires a more expensivedesign to protect electrical equipment.

An O-ring 282 seals the plates 276 on the thermo-electric devices 270and 272 against the housing 264. An aperture 284 through the housing 264aligns with an aperture 286 through the insulator 262 to place a chamber288 defined by the housing 264 into fluid communication with the inletmanifold 252. An outlet passage 290 in the housing 264 connects to anupper portion of the chamber 288 and to a second aperture 292 throughthe insulator 262 which in turn aligns with the outlet manifold 256 toplace the chamber 288 in fluid communication with the outlet manifold256. A safety thermostat 294 atop the housing 264 is wired outside ofthe control system to shut down heating of the vaporizer/condenser 250above a predetermined temperature. Temperature sensors 295 and 297measure temperature in the inlet manifold 252 andcondensing/revaporization section 254 respectively. A pressure sensor296 interfaces with the outlet manifold 256. Heat sinks 298 having fanhousings attach to each of the thermo-electric devices 270 and 272.

The outlet manifold connects to a valve manifold 300 which providesthree possible flow paths between the vaporizer/condenser 250 outletmanifold 256 and a valve manifold outlet 302 from the valve manifold300. The valve manifold outlet 302 communicates with the main chamber200. A main flow passage 304 is controlled by a valve 306 which can opento allow flow through the main passage 304 to the valve manifold outlet302 or close to block such flow. The second passage is through anorifice 308 in an orifice plate 310 which provides a flow restriction toenhance the ability to preferentially draw water vapor from thevaporizer/condenser 250. A third potential passage is through a rupturedisk 312 which is designed to rupture in case of a catastrophicoverpressure within the housing chamber 288, such as in the unlikelyevent that an oxidizable sterliant such as hydrogen peroxide combuststherein. The orifice 308 could be moved to a position within theshut-off valve 306, similar to that described in reference to the valveelement 118 in FIGS. 3A and 3B.

In operation, the main chamber is first evacuated to a low pressuresufficient to induce vaporization, such as 0.4 torr and the valve 306 isclosed placing the vaporizer/condenser 250 into fluid communication withthe chamber 200 solely through the orifice 308. The inlet manifold 252is heated with the heater 260 and a quantity of sterliant solution suchas a 59% hydrogen peroxide/water solution is injected into the inletmanifold 252 where it vaporizes and diffuses into the housing 264through the apertures 286 and 284. The thermo-electric devices 270 and272 at this time are drawing energy out of the rods 278 and dissipatingit through the heat sinks 298 thus allowing the vaporized sterliant torecondense on the rods 278.

The temperature of the inlet manifold 252 can be controlled to slowlyvaporize the sterilant thus allowing the water to more quickly vaporizeand flow through the vaporizer 250 and out through the orifice 308 toconcentrate the remaining sterilant. The condenser/revaporizationsection 254 quite effectively concentrates the sterilant such that tospeed up the process a fast vaporization in the inlet manifold can beemployed while still achieving a high degree of concentration.

The condensate on the rods 278 tends to be more highly concentrated inthe sterilant. After a time, when the initial charge of sterilantsolution has been vaporized and a portion thereof condensed on to therods 278, the thermo-electric devices 270 and 272 are reversed to applyheat to the rods 278 and revaporize the sterilant. At this time, theheat sink 298 will still contain heat which had been extracted duringthe prior step and that heat can be used by the thermo-electric devices270 and 272 to very efficiently heat the rods 278 and revaporize thesterilant. This added efficiency improves the energy efficiently of thedevice and allows a smaller and more compact vaporize condenser 250 toprovide adequate heating and cooling. After the sterilant has beenrevaporized, the valve 306 is opened to allow efficient diffusion of thesterilant vapor into the main chamber 200.

If a second vaporizer/condenser 216 is employed, its structurepreferably mimics that of the vaporizer/condenser 250 without the inletmanifold 252. In such a system, after initial diffusion into the mainchamber 200, rods within the second condenser 216 would be chilled andthe pump 214 turned on to preferably extract water vapor from thecondensing sterilant. After a period of time when sterilant hascondensed, the rods would be heated to revaporize the sterilant and thepump 214 turned off. This revaporized sterilant would have somewhathigher concentration and would then re-diffuse into the chamber 200 tofurther enhance the sterilization process.

Other system arrangements are possible. FIG. 16 illustrates analternative embodiment which can enhance efficiency in conserving andconcentrating the germicide solution. In this system, a chamber 314containing a load 316 has a first condenser/vaporizer 318 connected to asource 320 of germicide solution and a second condenser/vaporizer 322.The first condenser vaporizer 318 is isolated from the source 320 by avalve 323 and from the chamber 314 by a valve 324. It also connects toan exhaust pump 325 and is isolated therefrom via a valve 326. Thesecond condenser vaporizer 322 is isolated from the chamber 314 by avalve 327 and connects to the pump 325 and is isolated therefrom via avalve 328. A vent 329 is also provided.

FIG. 17 illustrates a similar system 330 employing a singlecondenser/vaporizer 332 (of structure similar to the condenser/vaporizer250 with an additional outlet) connected to a sterilization chamber 334adapted to receive a load 336 of instruments to be sterilized. A vacuumpump 338 connects to the chamber 334 via a valve 340 and to thecondenser/vaporizer 332 via a valve 342. A three-way valve maysubstitute for valves 340 and 342. A source of germicidal solution 344connects to the condenser/vaporizer 332 and the chamber 334 has a vent346. During initial vaporization and concentration of germicide from thesource 344, valve 342 is closed. After the vapor is diffused into thechamber 334, valve 340 can be closed and the pump 338 used to draw vaporout of the chamber through the condenser/vaporizer 332 in its condensingmode to further concentrate the germicide. The concentrated germicide isthen revaporized and diffused back into the chamber 334.

The second condenser/vaporizer 216 of FIG. 9 can be used to maximizegermicide utilization when running a sterilization process with two fullcycles of vacuum, inject, diffuse and vent. Prior to venting during thefirst cycle, the pump 214 is run with the condenser/vaporizer 216 beingchilled to condense the germicide therein. The valves 220 and 218 areclosed during the venting process. During the subsequent pump down, thecondenser/vaporizer is kept chilled to keep the germicide from undulyvaporizing and being carried out of the system.

The systems of FIGS. 16 and 17 allow even more of the germicide to beretained between cycles in a two cycle process. Prior to venting in thefirst cycle germicide is condensed into the condenser/vaporizer 332.However, during the subsequent pump down it can be isolated from thepump via the valve 342 thus minimizing the tendency of the pump 338 topump the saved germicide out of the system during pump down.

In each of this type of system the steps of condensing and concentratingthe vaporized germicide and then revaporizing it can be repeated asneeded to further concentrate the germicide.

FIG. 18 illustrates a system 350 plumbed in an alternative fashion. Inthis system 350 a condenser/vaporizer 352 connects through a valve 354to a sterilization chamber 356 adapted to receive a load 358 and havinga vent 360. A vacuum pump 362 connects to the condenser/vaporizer 352through a valve 364, but has no separate connection to the chamber 356.A source 366 of germicide connects to the condenser/vaporizer 352.

FIG. 19, illustrates a system 370 plumbed as in FIG. 17, having acondenser/vaporizer 372 which connects through a valve 374 to asterilization chamber 376 adapted to receive a load 378 and having avent 380. A vacuum pump 382 connects to the condenser/vaporizer 372through a valve 384, but has no separate connection to the chamber 356.Rather than an inlet for germicide through the condenser/vaporizer 382,a source 386 of germicide solution is provided within the chamber 376.The source can be simple such as a well containing a quantity of liquidgermicide solution. Preferably, it is covered with a semi-permeablemembrane or filter so that liquid germicide can not be accidentallyspilled therefrom yet as the germicide vaporizes under low chamberpressures the vapors thus generated can pass through the membrane intothe chamber. In both systems the condenser/vaporizer 352 or 372concentrates the germicide via condensation and revaporization ofgermicide vapor as described above.

The invention has been described with reference to the preferredembodiments. Obviously, modifications and alterations will occur toothers upon reading and understanding the preceding detaileddescription. It is intended that the invention be construed as includingall such modifications and alterations insofar as they come within thescope of the appended claims or the equivalents thereof.

1. A method of providing a sterilant vapor for sterilizing an articlecomprising the steps of: a) placing the article into a sterilizationchamber; b) vaporizing a liquid sterilant solution comprising a solventand a sterilant to form a sterilant vapor; c) condensing at least aportion of the sterilant vapor onto a temperature controllable surface;d) evacuating an atmosphere adjacent the surface, the atmospherecontaining vaporized solvent, thereby leaving the condensed sterilantvapor with a higher concentration of sterilant than in step b); e)revaporizing the sterilant vapor which was condensed onto the surface;and f) contacting the article with the sterilant vapor which has beenrevaporized.
 2. A method of sterilizing an article according to claim 1wherein the surface is cooled to enhance condensation during step c). 3.A method according to claim 1 wherein the surface is heated to enhancerevaporization during step e).
 4. A method according to claim 1 whereinthe surface is located within the sterilization chamber.
 5. A methodaccording to claim 1 wherein the surface is located in a condenser whichis in fluid communication with the chamber.
 6. A method according toclaim 5 further comprising flowing the sterilant vapor from step b) intothe chamber, from the chamber into the condenser, and then performingstep c).
 7. A method according to claim 5 wherein the atmosphere whichis evacuated passes out of the condenser without further passing throughthe chamber.
 8. A method according to claim 7 wherein the condenser isisolated from the sterilization chamber during step d).
 9. A methodaccording to claim 1 wherein the surface is used to vaporize the liquidsterilant solution in step b).
 10. A method according to claim 9 andfurther comprising flowing the sterilant vapor from step b) into thechamber, from the chamber into the condenser, and then performing stepc).
 11. A method according to claim 1 and further comprising repeatingsteps c), d) and e).
 12. An apparatus for delivering a sterilant vaporto an article during a sterilization process, the apparatus comprising:a sterilization chamber for containing the article; a vaporizer in fluidcommunication with the sterilization chamber; a temperature controllablecondensing surface within or in fluid communication with thesterilization chamber; a vacuum pump in fluid communication with thecondensing surface.
 13. An apparatus according to claim 12 and furthercomprising a cooler associated with the condensing surface whereby tocool the condensing surface.
 14. An apparatus according to claim 12 andfurther comprising a heater associated with the condensing surfacewhereby to heat the condensing surface.
 15. An apparatus according toclaim 12 wherein the condensing surface is located within thesterilization chamber.
 16. An apparatus according to claim 12 whereinthe condensing surface is located within a separate condenser which isin fluid communication with the sterilization chamber.
 17. An apparatusaccording to claim 16 wherein the condenser is located between thevaporizer and the chamber.
 18. An apparatus according to claim 16wherein the condenser is located between the chamber and the pump. 19.An apparatus according to claim 16 and further comprising a valvebetween the condenser and the sterilization chamber whereby to isolatethe condenser from the sterilization chamber.
 20. An apparatus accordingto claim 12 wherein the condensing surface is within the vaporizer.